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In your studies 'Drug Regulator Affairs'

©Volker Lannert / Universität Bonn

Master's thesis


As part of the continuing education Master's degree programme, Master's theses are written on relevant topics in the field of 'Drug Regulatory Affairs' using scientific methods. The topics are highly topical, diverse and the results are both of interest in a scientific context and relevant to many areas of activity in 'Drug Regulatory Affairs'.

Here you will find all Master's theses written since the year 2000, including the title and a summary. In this collection, many Master's theses can also be viewed and downloaded in full text.

Further information on Master's theses (e.g. registration, processing) can be found in our ‘Master's thesis guidelines/Leitfaden für die Anfertigung einer Masterarbeit’ (in German) and in the ‘Information leaflet - Master's thesis’ at

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Do you have any questions or are you interested in the full text of a Master's thesis that is not listed here?
Please feel free to contact me.

Dr. Jasmin Fahnenstich

Dr. Jasmin Fahnenstich

Study programme manager

Phone: +49 (0) 228 - 9268 6806

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Master's thesis

The collection of Master's theses can be searched and sorted by entering keywords.

Year Name Title Full text Summary
2005 Dr. Thomas Stoiber Introduction of electronic systems supporting the submission management of the Regulatory Affairs department in a medium-sized pharmaceutical company, with special focus on the implementation of the ICH eCTD standard
2005 Dr. Karin Streso Demarcation of medicinal products and food in the European Union - Focus on food supplements ***
2005 Dr. Michael Sych Structure and implementation of an adequate quality assurance system in a pharmaceutical start-up company ***
2005 Ute Ukelis Replacement of In Vivo ATC Studies by In Vitro Cytotoxicity Methods
2005 Elke Wehres-Losch Die Anmeldung klinischer Prüfungen in Deutschland nach der 12. AMG-Novelle – Erste Erfahrungen und kritische Aspekte aus Sicht der pharmazeutischen Industrie ***
2005 Dr. Bernhard Wenkers Balancing Regulatory and Economic Aspects in the Development of Generics – a Business Case ***
2005 Dr. Oliver Weyand Generic Medicinal Product Portfolio from a Regulatory and Business Development point of view ***
2005 Dr. Arno Wiehe Data protection for the development of known drug substances - Changes with the review of EU legislation ***
2005 Matthias Wilken Empfehlungen zur Erstellung eines Maßnahmeplans unter Anpassung an die aktuellen gesetzlichen Vorgaben unter spezieller Berücksichtigung der 12. AMG-Novelle ***
2005 Dr. Doris Wolf Safety reporting in clinical trials
2005 Hiu Wah Yuen Implementing CMC Section of the Clinical Trial Directive
2004 Dr. Christine Binninger Regulatory standards on clinical trials for medical devices and medicinal products in case of orthopedically used hyaluronic acid
2004 Lada Bogdanovic Implications of the EU Clinical Trial Directive 2001/20/EC on the conduct of paediatric studies in Germany
2004 Dr. Franz-Josef Braun The Legal Framework for Parallel Trade in Pharmaceuticals for Human Use in the European Economic Area ***
2004 Dr. Ingeborg Cebulla Changes to biological medicinal products (Case Study: Vaccines) ***
2004 Dr. Ulrike Domack Regulatory Science on Orphan Drug Application within Paediatric Field ***
2004 Dr. med. Klaus Eckhardt Clinical development of a new chemical entity compared to a somatic cell therapy product for Parkinson´s disease in the regulatory framework of the EU
2004 Dr. Angelika Freund "Regulations Concerning "Off-Label-Use" of Medicinal Products in Germany" ***
2004 Dr. Doreen Gerlach The "Arzneimittel-TSE-Verordnung" in Germany - Motives for this regulation and its consequences for medicinal products containing gelatine
2004 Britta Ginnow Impact of the new Variation Regulations 1084/2003 and 1085/2003 on the industrial practice of a multinationally operating pharmaceutical company with regard to the EU enlargement and the multinational procedure in performing variations ***
  • Total: 969